FDA Devices Critical Class I Terminated

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD)

Reported: January 27, 2021 Initiated: November 13, 2020 #Z-0879-2021

Product Description

Reason for Recall

There is potential for fractures which results in the inability to delivery therapy.

Details

Recalling Firm: Boston Scientific Corporation
Units Affected: 47000 units
Distribution: Worldwide distribution including US and US territories, Canada, Latin America, Europe, Middle East, Africa, and Asia-Pacific region
Location: Saint Paul, MN

Frequently Asked Questions

What product was recalled? ▼

EMBLEM S-ICD Subcutaneous Electrode Model 3501. Component of implantable cardioverter defibrillator (ICD). Recalled by Boston Scientific Corporation. Units affected: 47000 units.

Why was this product recalled? ▼

There is potential for fractures which results in the inability to delivery therapy.

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on January 27, 2021. Severity: Critical. Recall number: Z-0879-2021.